5425W-13: Celgene AML

CRC 13084: Oral Azacitidine Plus Best Supportive Care Versus Best Supportive Care as Maintenance Therapy in Subjects with Acute Myeloid Leukemia in Complete Remission

Type of Study
Cancer (Oncology) - Leukemia
Swedish Cancer Institute
Short Description

Purpose: Study to compare efficacy and safety of oral Azacitidine plus best supportive care versus best supportive care as maintenance therapy in Subjects with Acute Myeloid Leukemia (AML), age = or >55 years, who have achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) after induction with intensive chemotherapy with or without consolidation chemotherapy.

Open to Enrollment
Principal Investigator
Michael Milder, M.D.
Eligibility Notes
  • Male or female subjects ≥ 55 years of age
  • Newly diagnosed, confirmed de novo AML or AML Secondary to prior MDS
  • First CR/CRi with induction therapy ± consolidation therapy within 90 days of achieving CR
  • Eastern Cooperative Oncology Group (ECOG) performance status - 0, 1, 2, 3
  • No AML with inv(16), t(8;21), t(16;16), t(15;17), or t(9;22) or molecular evidence of such translocations
  • No prior bone marrow or stem cell transplantation
  • Not a  candidate for allogeneic bone marrow or stem cell transplant
  • No CR/CRi following therapy with hypomethylating agents
  • No diagnosis of malignant disease within the previous 12 months
  • No proven Central Nervous System (CNS) leukemia
More Info Link
Additional information about the study summary and eligibility criteria may be viewed on the U.S. National Institutes of Health (NIH) website.
(206) 215-3086